U.S. patent application number 11/799371 was filed with the patent office on 2007-09-06 for elastically deformable fabric with gel coated surface.
Invention is credited to Allen C. SR. Rasor.
Application Number | 20070207688 11/799371 |
Document ID | / |
Family ID | 46327812 |
Filed Date | 2007-09-06 |
United States Patent
Application |
20070207688 |
Kind Code |
A1 |
Rasor; Allen C. SR. |
September 6, 2007 |
Elastically deformable fabric with gel coated surface
Abstract
An applique for the skin for the management of scars that
includes an elastically deformable woven fabric having an
imperforate, tacky gel coating on one side thereof. The fabric is
preferably woven from a thread comprising an elastic polyester or
polyether fiber such as LYCRA.RTM. or Spandex. The gel coating,
which is applied to one side of the fabric, is preferably silicone
gel. The applique is used for the management of hypertrophic skin
conditions.
Inventors: |
Rasor; Allen C. SR.;
(Templeton, CA) |
Correspondence
Address: |
Michael G. Petit
P.O. Box 91929
Santa Barbara
CA
93190-1929
US
|
Family ID: |
46327812 |
Appl. No.: |
11/799371 |
Filed: |
April 30, 2007 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10735015 |
Dec 12, 2003 |
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11799371 |
Apr 30, 2007 |
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60442646 |
Jan 23, 2003 |
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Current U.S.
Class: |
442/59 |
Current CPC
Class: |
A61L 15/60 20130101;
Y10T 442/2525 20150401; Y10T 442/20 20150401 |
Class at
Publication: |
442/059 |
International
Class: |
B32B 5/02 20060101
B32B005/02 |
Claims
1. A topical applique operable for adhesion to the skin adjacent to
and overlying a healed wound, the topical applique thereafter being
operable for mimimizing scar formation, the topical applique
consisting of: (a) an elastically extensible fabric woven from
elastically extensible fibers and having interstitial openings
between said fibers, said elastically extensible fabric having an
upper surface and a lower skin-facing surface; and (b) an
imperforate layer of silicone gel coating said lower skin-facing
surface of said elastically extensible fabric.
2. The topical applique of claim 1 wherein said imperforate layer
of silicone gel has an upper surface affixed to said lower
skin-facing surface of said elastically extensible fabric and a
lower skin-contacting surface in oposition thereto, said applique
further comprising a sheet of a release material releasably affixed
to said lower skin-contacting surface of said imperforate layer of
silicone gel.
Description
REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation in part of U.S. patent
application Ser. No. 10/735,015, filed Dec. 12, 2003, which claims
the benefit of U.S. Provisional Application No. 60/442,646, filed
Jan. 23, 2003.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to an applique consisting of
an elastically extensible woven fabric having an imperforate
silicone gel coating on one surface thereof which is applied to the
skin to overlie a closed wound for the reduction and management of
scar tissue formation.
[0004] 2. Prior Art
[0005] Wound dressings are applied directly to wounded or diseased
tissue for the absorption of secretion, for protection from trauma,
for administration of medicine, to keep the wound clean, or to stop
bleeding. Prior art dressings address such issues by providing
varying degrees of wound ventilation, of hydrophobic/hydrophyllic
capability, and other characteristics depending upon the immediate
need. However, the effectiveness of the treatment is sometimes
limited by the degree of physical contact between the skin and the
dressing itself. Indeed, irregular contours of the body present a
challenging topology to customarily flat medical dressings. In the
case of pressure dressings, this problem is solved by means of an
external wrap. However, the presence of the wrap may interfere with
important functions of the dressing, such as its ventilating
properties. The location of the wound may also make adequate
application of an external wrap impossible.
[0006] Spandex was the first manufactured elastic fiber, and was
introduced by Dupont under the tradename Lycra.RTM. in 1958. Due to
its improved strength and ability to hold a dye, spandex replaced
extensible fabrics woven from rubber fibers in most garment
applications. Spandex fiber is a long-chain synthetic polymer
comprised of at least 85% segmented polyurethane. The polymer chain
is a segmented block copolymer containing long, randomly coiled,
liquid soft segments that move to a more linear, lower entropy
structure. The hard segments act as "virtual cross-links" that tie
all the polymer chains together into an infinite network. This
network prevents the polymer chains from slipping past each other
and taking on a permanent set or draw. When the stretching force is
removed, the linear, low entropy, soft segments move back to the
preferred randomly coiled, higher entropy state, causing the fiber
to recover to its original shape and length. The segmented block
copolymer is extruded into a fiber comprised of a plurality of
coalesced fine filaments. The fibers are woven to provide an
extensible fabric. The size and density of the interstices in the
fabric depend on the "thread count" and can generally be varied in
the weaving process.
[0007] Topical dressings such as wound dressings in the form of
both perforate and imperforate elastomeric sheets, one side of
which has a gel coated thereon, are well known in the art.
Nonextensible woven fabrics having one side coated with a gel are
also known. Examples of such prior art wound dressings are
disclosed in U.S. Pat. Nos. 4,991,574 and 4,838,253. Fabo, in U.S.
Pat. No. 5,340,363, discloses a liquid-permeable wound dressing
comprising a mesh net of a reinforcing fabric wherein the adjacent
fibers defining the interstices of the fabric are impregnated with
an elastic hydrophobic gel such as silicone gel but the interstices
contain openings to permit fluid to flow through the dressing.
Surprisingly, no dressings for topical application have been
described wherein the dressing comprises a sheet of fabric woven
from elastic fibers and having interstices therein wherein one side
of the fabric is coated with an imperforate layer of a hydrophobic
gel to occlude the interstice openings and provide a tacky adhesive
surface and wherein the opposing surface of the fabric is uncoated
and retains the texture and feel of the fabric.
[0008] It is generally known in the art that wound dressings
preferably be perforate, at least to the passage of air
therethrough. Wounds "weep", and a layer of absorbant material
normally comprises at least one layer of a wound dressing to absorb
the fluid emanating from the wound. The absorbant layer is either
in direct contact with the wound of has a fluid-permeable layer of
material interposed between the absorbant layer and the wound.
After the wound heals, it is desireable to minimize post-traumatic
scar formation. The structural considerations required in an
applique for the management (i.e., the minimization) of scar
formation are different than those required in the structure of a
wound dressing. For example, it is unnecessary to include an
absorbant layer in the applique as is the case with wound
dressings. Notwithstanding the improvements in wound dressings that
have been developed in recent years, there remains a need for an
applique that may be applied over a healed or closed wound to
minimize scar formation.
SUMMARY
[0009] It is an object of the present invention to provide an
applique for adhesion to the skin overlying a healed wound, the
applique thereafter being operable for minimizing scar formation.
The applique consists of a sheet of fabric woven from elastically
extensible fibers having an imperforate, homogeneous layer of
silicone gel coated on a lower, skin-facing surface of the fabric,
the upper, opposing surface of the fabric being uncoated.
[0010] The features of the invention believed to be novel are set
forth with particularity in the appended claims. However the
invention itself, both as to organization and method of operation,
together with further objects and advantages thereof may be best
understood by reference to the following description taken in
conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] FIG. 1 is a perspective and transverse cross-sectional view
of a scar management applique in accordance with the present
invention.
[0012] FIG. 2 is a plan view illustrating a process for making a
scar management applique in accordance with FIG. 1.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0013] With reference to FIG. 1, a skin applique 10 (i.e., an
applique adapted for releasable attachment to the skin) consisting
of a sheet of elastically extensible fabric 11 having an
imperforate layer of a pure, homogeneous silicone gel 12 coated on
a lower skin-facing side thereof. The term "elastically extensible
fabric", as used herein, means a fabric woven or formed from
elastically extensible fibers. A protective release sheet of a
suitable releasing material such as polycarbonate film is indicated
at numeral 13. The sheet of release material 13 is loosely affixed
to a tacky lower skin-contacting surface of the silicone gel layer
in opposition to the fabric 11, and is easily separated from the
silicone gel layer. The silicone gel layer 12 covering the lower
surface of the fabric 11 is continuous, impervious to liquids and
is substantially impervious to air because the silicone gel layer
12 does not have apertures therein. The silicone gel layer is
forced into (but not through) the interstitial spaces between
adjacent fibers in the woven fabric and is firmly affixed to the
fabric. The upper surface of the fabric (i.e., the surface of the
fabric opposed to the gel-covered surface) remains gel-free and
retains the texture of the fabric. The lower skin-contacting
surface of the silicone gel layer is tacky and, when the sheet of
release material 13 is removed therefrom, provides adhesive means
for attaching the scar management applique 10 to the surface of the
skin bearing the scar tissue. The release layer 13 protects the
tacky skin-contacting surface of the silicone gel layer 12 until
ready for use and is peeled from the dressing to expose the gel
layer 12 prior to use.
[0014] Turning now to FIG. 2, a process for fabricating the scar
management applique 10 is illustrated in plan view. A film of
release material 13, such as a polycarbonate sheet, is fed from a
bulk roll 20, and brought into and through the gel coating
application device 21, wherein the sheet of release material 13
receives a layer of pure, unvulcanized liquid silicone gel 12
having a predetermined thickness. Upon leaving the coating device
21, a sheet of elastically extensible fabric 11 such as Spandex is
introduced directly onto the exposed liquid silicone gel surface 12
layered upon the sheet of release material 13 prior to entering the
heat-curing oven 22. While passing through the oven 22, the
silicone gel component layer 12 is cured, or transformed by the
heat into its final viscous gel state. After leaving the oven 22,
the bulk, finished product 10 is then rolled onto a take-up reel 23
for storage, secondary bulk cutting, or final shape cutting.
[0015] A suitable gel composition for coating the carrier sheet 13
(i.e., the sheet of release material) is available as a 2-part
liquid blended in a 1:1 ratio such as MED-6340 (NuSil Technology,
Carpinteria, Calif. 93013). MED-6340 is supplied as a Part A and a
Part B. The mixture is deaerated under vacuum prior to layering the
liquid onto the carrier/release sheet 13. The firmness of the cured
silicone gel layer can be increased by increasing the amount of
Part B relative to Part A in the mixture. The silicone gel layer is
preferably heat-cured (i.e., hot-air vulcanized) by exposure to hot
air at a temperature of about 300 degrees F. for 2-3 minutes in the
"tunnel" oven 22. It is noted that a variety of curing conditions
may be employed. For example, the silicone gel will cure at room
temperature given sufficient time.
[0016] While particular embodiments of the present invention have
been illustrated and described, it would be obvious to those
skilled in the art that various other changes and modifications can
be made without departing from the spirit and scope of the
invention. It is an important feature of the scar management
applique presented hereinabove that the silicone gel layer is pure
and homogeneous. No therapeutic agents are required as additives to
the scar-contacting silicone gel layer in order for the applique to
be operable for its intended scar management function. In addition,
the woven fabric may comprise any elastomeric fiber provided that
the fiber is elastically deformable. It is another important
feature and advantage of the present scar management applique that
the elastically extensible fabric, together with the cohesive
nature of the silicone gel layer coated thereon, enables the
dressing to be stretched prior to application to the skin to
compress the scar. The compression of the scar during exposure of
the scar to the silicone gel layer, enhances the ability of the
applique to minimize scar formation. The artisan will appreciate
that the utility of the applique described hereinabove could be
extended to non-medical applications such as impact damping inserts
for running shoes. It is therefore intended to cover in the
appended claims all such changes and modifications that are within
the scope of this invention.
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